Phase I/II Study of TS-1/Oxaliplatin(SOX) for patients with unresectable advanced or recurrent gastric cancer
Phase 1
Recruiting
- Conditions
- unresectable advanced or recurrent gastric cancer
- Registration Number
- JPRN-UMIN000015807
- Lead Sponsor
- Gunma University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
Not provided
Exclusion Criteria
1) History of serious drug hypersensitivity 2) Pregnant, lactating or women of child-bearing potential. Men who want get partner pregnant 3) Active infections 4 4) Serious complications 5) Serious heart disease 6) Peptic ulcers 7) Sensory neuropathy 8) Diarrhea 9) A case with abdominal dropsy and the hydrothorax to need waste fluid by the sustained drainage custody 10) Brain metastasis 11) Other active malignancies (Nondisease period less than 5 years) 12) Continuous steroid treatment 13) Any other cases who are regarded as inadequate for study enrollment by the investigator 14) Administration contraindication of L-OHP , TS-1 , 5-F
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method [Phase I part] To determine recommended dose (RD) and maximum tolerated dose (MTD) [Phase II part] progression-free survival (PFS)
- Secondary Outcome Measures
Name Time Method